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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Figure 1 : adapted from Saha, G. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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FDA warning letters highlight data integrity issues

European Pharmaceutical Review

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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FDA publishes paper on AI/ML in drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. According to the FDA, the organisation has seen “a rapid growth in the number of submissions that reference AI/ML” over the past few years.

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New Research Reveals Three Ways Pharma Can Better Prioritize Payer Audiences

PM360

The pandemic had a huge impact on the way population health decision-makers (PHDMs) navigate our industry, and now that it’s clear many of these shifts are here to stay, pharmaceutical manufacturers need to adjust accordingly. Published online January 10, 2023. Accessed March 23, 2023. References: 1.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts. Due diligence teams will focus on two key areas: the standard of the facilities and the pharmaceutical quality system.

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